Trilogy Evo TR2110X15BRecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00606959055551), received between May 17, 2024 and Jun 26, 2026 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Device Sensing Problem” (7 reports).

3 FDA recall records name this device's identifier, 3 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

1. Oct 7, 2024Class IOpen, Classified

   Potential for in-line nebulizer configuration in certain locations to result in aerosol deposit accumulation on the device's internal flow sensor, which could lead to inaccurate flow measurements.

   Z-0291-2025 · Root cause: Device Design · Recall details · FDA record ↗

2. Jul 16, 2024Class IOpen, Classified

   Firm has released a mandatory software update Version 1.05.10.00 and a User Manual addendum for affected ventilators. These updates resolve safety issues identified in earlier recalls.

   Z-2944-2024 · Root cause: Device Design · Recall details · FDA record ↗

3. Mar 19, 2024Class IOpen, Classified

   Potential for sudden loss of ventilation due to Battery Depleted or Loss of Power alarm while unit has sufficient power.

   Z-1504-2024 · Root cause: Device Design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 26, 2026Device Sensing Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A PATIENT EXPERIENCED AN INTERRUPTION IN THERAPY WHILE USING A TRILOGY EVO DEVICE AS IT WAS REPORTED TO STOP OPERATING. THE PATIENT EXPERIENCED A TEMPORARY INTERRUPTION IN THERAPY, AND A BACKUP DEVICE WAS REQUIRED TO CONTINUE TREATMENT. NO PATIENT HARM OR INJURY WERE REPORTED. THE TRILOGY EVO DEVICE WAS EVALUATED AT THE CUSTOMER SITE. DURING THE EVALUATION, IT WAS NOTED THAT THERE WAS A SIGNIFICANT AMOUNT OF DUST THAT HAD ACCUMULATED IN THE MACHINE FLOW SENSOR. IT WAS ALSO DETERMINED THAT THE PARTICULATE FILTER, WHICH SHOULD BE INCLUDED IN THE DEVICE PACKAGE, WAS NOT PROVIDED WITH THE DEVICE. THE HOME HEALTHCARE PROVIDER ASSUMED THAT THE FILTER WAS NOT REQUIRED FOR HOME USE AND CONTINUED TO USE THE DEVICE WITHOUT IT. AS A RESULT, ENVIRONMENTAL DUST ACCUMULATED IN THE MACHINE FLOW SENSOR OVER TIME, CAUSING FAILED OPERATION OF THE SENSOR. THE MACHINE FLOW SENSOR WAS REPLACED TO ADDRESS THE ISSUE. THE DEVICE WAS TESTED AND PROPER OPERATION WAS CONFIRMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25640828 ↗
• MalfunctionJun 26, 2026Electrical /Electronic Property Problem; Device Sensing Problem; Device Contamination with Chemical or Other Material; Power Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A PATIENT EXPERIENCED THE TRILOGY EVO DEVICE HAD STOPPED WORKING. THE DEVICE WAS REPLACED WITH ANOTHER DEVICE. THERE WAS NO ALLEGATION OF SERIOUS OR PERMANENT HARM OR INJURY. NO MEDICAL INTERVENTION WAS SPECIFIED BY THE PATIENT. THE TRILOGY EVO DEVICE WAS RETURNED TO THE MANUFACTURER SERVICE CENTER FOR EVALUATION, AND THE CUSTOMER¿S COMPLAINT WAS CONFIRMED. DURING THE EVALUATION IT WAS NOTED THAT THERE WAS A SIGNIFICANT AMOUNT OF DUST HAD ACCUMULATED ON THE MACHINE FLOW SENSOR AFTER ONLY SIX MONTHS OF USE. IT WAS DETERMINED THAT THE PARTICULATE FILTER WAS NOT PROVIDED WITH THE DEVICE. THE HOME HEALTHCARE PROVIDER ALLEGED THAT THE FILTER WAS NOT REQUIRED FOR HOME USE AND CONTINUED TO USE THE DEVICE WITHOUT IT. THE SERVICE TECHNICIAN OBSERVED AN ERROR CODE, PRESSURE SENSOR MISMATCH, ON THE DEVICE'S ERROR LOG. IN CONCLUSION, THE DEVICE'S MACHINE FLOW SENSOR WAS REPLACED TO ADDRESS THE ISSUE. THE ROOT CAUSE IS CONFIRMED AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25637838 ↗
• MalfunctionJun 26, 2026Electrical /Electronic Property Problem; Device Sensing Problem

  A TRILOGY EVO DEVICE WAS RETURNED TO A SERVICE CENTER FOR SERVICE DUE TO AN ALLEGATION OF A VENTILATOR SERVICE REQUIRED ALARM WHILE IN USE. THE PATIENT EXPERIENCED A TEMPORARY INTERRUPTION IN THERAPY, AND A BACKUP DEVICE WAS REQUIRED TO CONTINUE THE TREATMENT. THERE WAS NO HARM OR INJURY REPORTED. DURING THE EVALUATION, A VENTILATOR SERVICE REQUIRED ERROR CODE E384 (EVT_PRESS_SENSOR_MISMATCH) WAS DISCOVERED IN THE EVENT LOG, INDICATING THE DEVICE SOFTWARE DETECTED A LARGE PRESSURE DROP BETWEEN THE MONITOR AND OUTLET PRESSURE SENSORS. THE FLOW SENSOR WAS FOUND TO HAVE DUST CONTAMINATION, WHICH CAUSED THE SENSOR TO BECOME UNUSABLE, AND WAS REPLACED TO ADDRESS THIS ERROR CODE. THE DEVICE WAS TESTED AND PROPER OPERATION WAS CONFIRMED. ADDITIONALLY, THE PARTICULATE FILTER WAS MISSING FROM THE DEVICE. THE DEVICE WAS FOUND TO BE USED WITHOUT THE FILTER, WHICH ALLOWED ENVIRONMENTAL DUST TO ACCUMULATE IN THE SENSOR. A FINAL REPORT IS BEING SUBMITTED. IF NEW INFORMATION BECOMES AVAILABLE FOLLOWING THE COMPLETION OF THE DEVICE REPAIR THAT CHANGES THE OUTCOME OF THE INVESTIGATION AND ASSOCIATED MEDICAL DEVICE REPORTING A FOLLOW UP/SUPPLEMENTAL REPORT WILL BE COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25636164 ↗
• MalfunctionMay 7, 2026Circuit Failure; Device Sensing Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A TRILOGY EVO VENTILATOR EXPERIENCED A VENTILATOR SERVICE REQUIRED ALARM. THERE WAS NO SERIOUS PATIENT HARM OR INJURY THAT OCCURRED OR WAS REPORTED. DURING EVALUATION OF THE DEVICE AT THE MANUFACTURER'S SERVICE CENTER, VENTILATOR SERVICE REQUIRED ALARM RELATING TO 'PRESS SENSOR MISMATCH' WAS FOUND IN THE DEVICE'S ERROR LOG. THE SERVICE TECHNICIAN STATES THAT THE SYSTEM PRINTED CIRCUIT ASSEMBLY (PCA) BOARD WAS INITIALLY REPLACED TO RESOLVE THE ISSUE, BUT THE ISSUE PERSISTED. IT IS NOTED THAT THE MACHINE FLOW SENSOR SHOWED THE PRESENCE OF FLUID OR SOLUTION INSIDE. THE MACHINE FLOW SENSOR WAS THEN REPLACED AS WELL IN ORDER TO ADDRESS THE ISSUE. THE DEVICE PASSED ALL FURTHER TESTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25110785 ↗
• MalfunctionDec 24, 2025Contamination; Device Sensing Problem; Contamination; Device Sensing Problem

  A VENTILATOR WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR EVALUATION. THERE WAS NO HARM OR INJURY REPORTED. DURING THE EVALUATION A SERVICE REQUIRED ALARM CONDITION INDICATING A PRESSURE SENSOR MISMATCH WAS OBSERVED. THE DEVICE WAS FOUND TO BE VERY DIRTY AND DUSTY. THE DEVICE'S INLINE FILTER WAS FOUND TO BE CLOGGED WITH DIRT AND DUST AND WAS REPLACED TO ADDRESS THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23888240 ↗
• MalfunctionDec 24, 2025Contamination; Device Sensing Problem; Contamination; Device Sensing Problem

  A VENTILATOR WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR EVALUATION. THERE WAS NO HARM OR INJURY REPORTED. DURING THE EVALUATION A SERVICE REQUIRED ALARM CONDITION INDICATING A PRESSURE SENSOR MISMATCH WAS OBSERVED. THE DEVICE WAS FOUND TO BE VERY DIRTY AND DUSTY. THE DEVICE'S INLINE FILTER WAS FOUND TO BE CLOGGED WITH DIRT AND DUST AND WAS REPLACED TO ADDRESS THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23888198 ↗
• MalfunctionOct 15, 2025Circuit Failure; Electrical /Electronic Property Problem; Device Sensing Problem; Circuit Failure; Electrical /Electronic Property Problem; Device Sensing Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A PATIENT EXPERIENCED A VENTILATOR SERVICE REQUIRED ALARM WHILE USING A TRILOGY EVO DEVICE. THERE WAS NO ALLEGATION OF SERIOUS OR PERMANENT HARM OR INJURY. NO MEDICAL INTERVENTION WAS SPECIFIED BY THE PATIENT. THE TRILOGY EVO DEVICE WAS RETURNED TO THE MANUFACTURER SERVICE CENTER FOR EVALUATION, AND THE CUSTOMER¿S COMPLAINT WAS CONFIRMED. DURING THE EVALUATION IT WAS NOTED THAT AN ERROR CODE, PRESSURE SENSOR MISMATCH (E-384), WAS OBSERVED IN THE DEVICE'S ERROR LOG. THE MANUFACTURER'S SERVICE TECHNICIAN DETERMINED THERE WAS A LEAK IN THE AIRWAY HAD CAUSED THE ISSUE TO OCCUR ON THE DEVICE. IN CONCLUSION, THE DEVICE'S BLOWER CAP, BLOWER BELLOWS, IN-LINE FILTER, IN-LINE PROXIMAL FILTERS, MACHINE FLOW SENSOR, MUFFLER ASSEMBLY, PROPORTIONAL VALVE, THREE-WAY SOLENOID VALVE, AND SYSTEM PRINTED CIRCUIT ASSEMBLY BOARD WERE REPLACED TO ADDRESS THE ISSUE. THE ROOT CAUSE IS CONFIRMED AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23304229 ↗
• MalfunctionAug 8, 2025Electrical /Electronic Property Problem; Mechanical Problem; Electrical /Electronic Property Problem; Mechanical Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING IT GIVES A WARNING: MAINTENANCE REQUIRED. THERE WAS NO HARM OR INJURY REPORTED. DURING TECHNICAL INSPECTION OF THE DEVICE BY THE DISTRIBUTOR, AN ERROR CODE RELATED TO THE ACTIVE EXHALATION CONTROL MODULE (AECM) AND AN ERROR CODE RELATED TO THE PRESSURE SENSOR WAS OBSERVED. EVT_AECM_FAILURE MEANS THE AECM VALVES ARE NOT PROPERLY ACTUATING DURING THE PROPER STAGES OF THE BREATH. EVT_PRESS_SENSOR_MISMATCH MEANS THE DEVICE SOFTWARE HAS DETECTED A LARGE PRESSURE DROP BETWEEN THE MONITOR AND OUTLET PRESSURE SENSORS (I.E. ACROSS THE MACHINE FLOW SENSOR). THE PROPORTIONAL VALVE, THE THREE-WAY SOLENOID VALVE, THE SYSTEM BOARD AND IN-LINE FILTERS WERE REPLACED TO ADDRESS THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22751357 ↗
• MalfunctionMay 17, 2024Unexpected Shutdown; Unexpected Shutdown

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING THAT THE DEVICE STOPPED WORKING, "SO THE PATIENT COULD NOT RECEIVE THE TREATMENT WHO HAS TO LIVE WITH DEVICE." PER REPORT OF THE EVENT, THE DEVICE WAS CONNECTED TO THE PATIENT AND WAS OPERATING IN SYNCHRONOUS INTERMITTENT MANDATORY VENTILATION (SIMV) MODE, THE PATIENT'S TREATMENT STOPPED AND HIS FATHER PROVIDED "MANUAL THERAPY WITH AMBU." THE PATIENT USED THE DEVICE WITH A CONCENTRATOR. THE DEVICE DID NOT ALARM AND STOPPED SUDDENLY. NO FURTHER CLINICAL DETAILS WERE REPORTED. THE MANUFACTURER'S INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19345007 ↗